March 25, 2019

A geneticist’s perspective on regulating DNA as a drug

A geneticist’s perspective on regulating DNA as a drug

An increasing number of scientists are speaking out against a 2017 FDA draft guidance that would treat the genetic alterations introduced to animals through modern biotechnologies or rDNA techniques as “drugs.” 

“Ultimately this ruling may hinder the use of gene editing to introduce useful attributes – like disease resistance – into U.S. livestock populations,” writes Alison Van Eenennaam, an animal scientist and geneticist at the University of California, Davis, in a recent piece for The Conversation.

Van Eenennaam’s piece, titled “Gene-edited food regulations: whether it’s a plant or animal shouldn’t matter, but it does now,” lays out the benefits of gene-editing. Her work has shown that altering the genomes of many livestock species can improve animal welfare, sustainability and efficiency in animal production. As she explains, DNA does not work like a drug. We eat “mutations” in plant and animal foods every day, and research shows no risk in consuming DNA from species that have undergone more high-tech breeding processes, such as gene editing or genetic engineering.

The animals themselves have also not been given a “drug” by being bred with a specific genetic alternation. After all, animals have been bred for certain traits for thousands of years. New technologies just make this process more precise.

Regulators seem to agree with Van Eenennaam, at least when it comes to regulating plants, which are subject to rules for food. But the FDA draft guidance recommends treating “intentional” genetic alterations in animal products as drugs. As many have pointed out, this guidance would make it harder to get approval for animals that pose no risk.

“The mandatory approval process for animal drugs is understandably rigorous. It requires proof that the drug works, the absence of harmful residues in food animal products, and both animal and environmental safety,” Van Eenennaam explains. But DNA does not work like a drug, she explains, so this process should not apply.

This “drug” designation would also frighten consumers, Van Eenennaam writes. It would also be likely to drive more animal production to countries where the rules are not as stringent. Already, research and business are starting to shift. “U.S. animal geneticists are starting to move their gene-editing research to other countries,” Van Eenennaam adds. “Innovative startups are forming partnerships with foreign companies in countries with product risk-based regulatory systems.”

Van Eenennaam’s perspective is part of a growing movement to draw attention the the FDA’s draft guidance. The Cornell Alliance for Science is currently managing a petition that calls for “a harmonization of the U.S. regulatory approach to gene editing in food species so that both plant and animal breeders have access to gene editing innovations to introduce useful sustainability traits like disease resistance, climate adaptability, and food quality attributes into U.S. agricultural breeding programs.”

ASAS also has a policy statement available on the use of biotechnology in agriculture and the importance of science-based regulatory policies.